The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment

Trial Information

The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment

This study is a drug interaction study designed to study the effects of enalapril on
doxorubicin metabolism. Women with breast cancer for whom at least two cycles every 14 day
doxorubicin is planned will be considered for enrollment. Study participation will be for 2
treatment cycles of doxorubicin or approximately 4 weeks. Patients will receive a 14 day
course of daily enalapril in association with one cycle of doxorubicin and receive no study
agent during the other cycle allowing patients to act as their own control. The sequence of
enalapril dosing will be assigned by randomization at study enrollment. Blood samples for
pharmacokinetics will be drawn before and at 7 time points after each of the two doses of
doxorubicin. For each patient, serum doxorubicin and doxorubicinol concentrations both on
and off of enalapril will be compared.

Inclusion Criteria:

- Tissue diagnosis of a breast carcinoma

- The oncologist must have prescribed doxorubicin as part of the planned chemotherapy
regimen

- Have acceptable organ function within 14 days of enrollment defined as:

Type of Study:

Study Design:

Outcome Measure:

Increase or decrease in doxorubicin hydrochloride exposure

Outcome Description:

Doxorubicin plasma concentration (DPC) will be the primary pharmacokinetic (PK) measure of the exposure. Each patient will have PK performed twice - once with enalapril and once without enalapril. An increase of more than 115 ng/ml in DPC will be considered important.

Outcome Time Frame:

Before and After Receiving Enalapril

Safety Issue:

No

Principal Investigator

Anne H. Blaes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2008NTLS060

NCT ID:

NCT00895414

Start Date:

April 2009

Completion Date:

December 2012

Related Keywords:

Breast Cancer

stage I breast cancer

stage II breast cancer

stage IIIA breast cancer

stage IIIB breast cancer

stage IIIC breast cancer

stage IV breast cancer

Breast Neoplasms

Name

Location

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